Mustang Bio(US:MBIO)2025-11-07 21:06Clinical Development - The company is focused on developing CAR T therapies for hematologic malignancies and autoimmune diseases, with partnerships established with leading research institutions [101]. - As of June 30, 2025, 53 patients have been treated in an ongoing Phase 1 clinical trial for MB-106, and 20 patients have been treated in a separate Phase 1 trial [105]. - The FDA accepted the IND application for the combination therapy MB-109 in October 2023, targeting IL13Rα2+ relapsed or refractory glioblastoma and high-grade astrocytoma [104]. - The company is exploring the possibility of conducting an investigator-sponsored trial for MB-109, potentially starting in the second quarter of 2026 [108]. Financial Performance - The company has incurred substantial operating losses since inception and expects to continue incurring significant losses for the foreseeable future [110]. - The company has not generated any product sales from its candidates and has substantial doubt about its ability to continue as a going concern [102]. - For the three months ended September 30, 2025, total operating expenses decreased by 57% to $0.624 million from $1.457 million in 2024 [127]. - Research and development expenses for the three months ended September 30, 2025, were $(0.3) million, a decrease of approximately $0.4 million compared to $0.1 million in 2024 [128]. - General and administrative expenses for the three months ended September 30, 2025, were $1.0 million, down 32% from $1.4 million in 2024 [129]. - Net loss for the three months ended September 30, 2025, was $(0.468) million, a 67% improvement from $(1.410) million in 2024 [127]. - For the nine months ended September 30, 2025, research and development expenses were $(1.2) million, a decrease of approximately $9.4 million from $8.2 million in 2024 [133]. - General and administrative expenses for the nine months ended September 30, 2025, were $3.0 million, a decrease of 32% from $4.4 million in 2024 [136]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $3.5 million, compared to $9.4 million in 2024 [145]. - Net cash provided by financing activities was $14.5 million during the nine months ended September 30, 2025, primarily from the February 2025 Equity Offering [149]. - As of September 30, 2025, the company had cash and cash equivalents of $19.0 million and an accumulated deficit of $398.1 million [139]. - The company expects to continue incurring significant operating losses and may never become profitable, raising substantial doubt about its ability to continue as a going concern [140]. Capital and Funding - In July 2025, the company received approximately $7.1 million from warrant exercises, issuing about 2.9 million shares of common stock [112]. - The February 2025 Equity Offering raised approximately $6.8 million in net proceeds for working capital and general corporate purposes [116]. Licensing and Agreements - The company is in discussions with Fred Hutch regarding the potential termination of the CD20 License due to unpaid patent expenses [106]. - The company is classified as a "smaller reporting company," with a market value of shares held by non-affiliates below $700 million [125].